NCT02577718

Brief Summary

The objective of this Phase I/II pilot study is to evaluate the safety and effectiveness of a non- antibiotic chelator based lock solution that contains nitroglycerin in combination with sodium citrate and ethanol (NiCE lock solution) for prevention of central line associated bloodstream infection (CLABSI).

  • The primary objective of this study is to evaluate the safety and estimate the rate of adverse events associated with the NiCE lock solution.
  • The second primary objective is to estimate the rate of CLABSI in patients receiving the NiCE lock solution.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 16, 2015

Completed
16 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 6, 2017

Completed
Last Updated

November 6, 2017

Status Verified

October 1, 2017

Enrollment Period

8 months

First QC Date

October 13, 2015

Results QC Date

June 22, 2017

Last Update Submit

October 2, 2017

Conditions

Catheter-Associated InfectionsCatheter-Related Infections

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Drug-Related Hypotension

    Drug-related hypotension is defined as a significant drop in measured blood pressure (BP) that exceeds the normal BP variability of a patient by 30%, that is associated with clinical signs and symptoms (dizziness and syncope) and is unexplained by factors other than the lock solution (such as other antihypertensive drugs, sepsis, bleeding). BP variability will be based on the standard deviation (SD) of a patient's blood pressure measured in the 3 days preceding participation in this trial and will be calculated at the time of trial entry.

    From date of randomization until date of first Drug-Related Hypotension within 10 minutes of each flush, assessed up to 60 days

Secondary Outcomes (1)

  • Incidence of Catheter-Associated Infections

    60 Days

Study Arms (1)

Nitroglycerin-Citrate-Ethanol (NiCE)

EXPERIMENTAL

Antimicrobial Nitroglycerin-Citrate-Ethanol catheter lock solution was administered for 2 hours then flushed

Drug: Nitroglycerin-citrate-ethanol (NiCE)

Interventions

Nitroglycerin-citrate-ethanol (NiCE)DRUG

Lock solution instilled in catheter lumens for 2 hours then flushed. Administration for up to 30 days, daily as in-patient or once weekly as out-patient

Nitroglycerin-Citrate-Ethanol (NiCE)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Inpatients who have a long term central venous catheter (CVC)-and the CVC has been in place for at least 14 days and is expected to remain in place at least for 30 days after enrollment
  • The CVC consists of a 5.0 French size, dual-lumen, peripherally inserted central catheter
  • Patients who are willing and capable to provide Informed Consent
  • Patients who are willing and capable to follow the instructions required to complete the study
  • Females (of child bearing potential) and males (of child bearing potential) must be abstinent or agree to use birth control during the study.

You may not qualify if:

  • Patients who have an antimicrobial CVC.
  • Patients who have a short term CVC that have been placed in ICU (mainly rigid wall CVCs placed for acute care in ICU).
  • Patients who are hypotensive with a systolic blood pressure reading of \<110 mmHg at any time over the 3 days prior to study entry
  • Patients who are not awake, not alert, or who cannot express pain or discomfort related to the catheter locks
  • Patients with an existing local or systemic infection as defined by evidence of fever (a body temperature \> 38.0o C with two readings taken at least 10 minutes apart or one body temperature \> 38.3o) and any of the following within 24 hours of enrollment: Pulse rate \> 100 beats/min.; Respiratory rate \> 20/min.; WBC count \>12,000/mm3, \<4,000/mm3 or differential count showing \>10% band forms. Patient will still be eligible for the study if the participant's white blood cell count (WBC) is outside normal limits due to chemotherapy treatment or underlying conditions. Systolic blood pressure \<90 mm Hg.
  • Signs and symptoms of localized catheter-related infection (tenderness and/or pain, erythema, swelling, purulent exudates within 2 cm of entry site)
  • Patients with an occluded (partially or totally) catheter defined as inability to either withdraw blood or instill 3cc of fluid without resistance through any catheter lumen
  • Patients with multiple co-existing central venous catheters at the time of enrollment will not be enrolled.
  • Patients in whom the lock solution application will interfere with routine treatment of the underlying disease
  • Patients with a known history of allergic reaction to ethanol, nitroglycerin, or citrate.
  • Female patients who are pregnant or breast feeding
  • Patients who are on disulfiram, metronidazole or are dependent on alcohol
  • Patients receiving phosphodiesterase type 5 (PDE-5) inhibitors (such as sildenafil, tadalafil, vardenafil).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Chaftari AM, Hachem R, Szvalb A, Taremi M, Granwehr B, Viola GM, Amin S, Assaf A, Numan Y, Shah P, Gasitashvili K, Natividad E, Jiang Y, Slack R, Reitzel R, Rosenblatt J, Mouhayar E, Raad I. A Novel Nonantibiotic Nitroglycerin-Based Catheter Lock Solution for Prevention of Intraluminal Central Venous Catheter Infections in Cancer Patients. Antimicrob Agents Chemother. 2017 Jun 27;61(7):e00091-17. doi: 10.1128/AAC.00091-17. Print 2017 Jul.

    PMID: 28416559RESULT

MeSH Terms

Conditions

Catheter-Related Infections

Condition Hierarchy (Ancestors)

Infections

Results Point of Contact

Title
Dr. A M Chaftari
Organization
MD Anderson Cancer Center
achaftar@mdanderson.org
7137923491

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2015

First Posted

October 16, 2015

Study Start

November 1, 2015

Primary Completion

June 22, 2016

Study Completion

October 1, 2016

Last Updated

November 6, 2017

Results First Posted

November 6, 2017

Record last verified: 2017-10

Locations

US(1)